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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00006851 |
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Date of registration:
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09/10/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Correlation of subjective visual parameters with morphologic parameters in reactivation of exsudative maculopathies
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Scientific title:
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Correlation of subjective visual parameters with morphologic parameters in reactivation of exsudative maculopathies |
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Date of first enrolment:
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15/10/2014 |
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Target sample size:
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1200 |
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Recruitment status: |
Pending |
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URL:
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http://drks.de/search/en/trial/DRKS00006851 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: diagnostic
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Christoph
Ehlken |
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Address:
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Killianstr. 5
79106
Freiburg
Germany |
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Telephone:
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0761/270-40010 |
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Email:
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christoph.ehlken@uniklinik-freiburg.de |
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Affiliation:
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Klinik für AugenheilkundeUniversitätsklinikum Freiburg |
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Name:
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Christoph
Ehlken |
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Address:
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Killianstr. 5
79106
Freiburg
Germany |
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Telephone:
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0761/270-40010 |
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Email:
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christoph.ehlken@uniklinik-freiburg.de |
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Affiliation:
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Klinik für AugenheilkundeUniversitätsklinikum Freiburg |
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Key inclusion & exclusion criteria
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Inclusion criteria: first examination of patients with maculopathy (age related maculopathy, diabetes, retinal vein occlusion, myopia, other diseases with development of choroidal neovascularisation) having received intravitreal injections with anti-VEGF (bevacizumab, ranibizumab, aflibercept) who were adjudged to be not in need of further treatment and were appointed to control examinations in the "IVOM-OCT-Sprechstunde"
Exclusion criteria: examination other than primary examination, other interventions (e.g. injection of TAC, Jetrea, Ozurdex), surgery of the study eye in the intervall between last intravitreal injection and OCT control
Age minimum:
18 Years
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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H35.3
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Degeneration of macula and posterior pole
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H35.3
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Intervention(s)
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Group 1: non-interventional study
retrospective data analysis of all patients who were examined in the clinical "IVOM-OCT-consultation" (clinical control of the success of treatment about 8 weeks after the last intravitreal injection, 4 weeks after the first control of success). If several appointments in the "IVOM-OCT-consultation" have taken place only the first documented appointment will be analysed (analysis of the documented subjective
estimation of visual acuity and metamorphopsia, analysis of the documented visual acuity, analysis of the executed OCT)
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Primary Outcome(s)
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specificity and sensitivity of subjective parameter (e.g. visual acuity, metamorphopsia; evaluation of the subjective devolopment as defined by better / worse / equal) in the evaluation of activity of maculopathy in age related maculopathy, retinal vein occlusion, diabetic retinopathy and other maculopathies
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Secondary Outcome(s)
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Differences in specificity and sensitivity of the above-named parameter in different diseases, identification of characteristics of the morphology in reactivated disease, correlation of these characteristics with subjective parameter, correlation with basic data (eye function, age)
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Source(s) of Monetary Support
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Klinik für AugenheilkundeUniversitätsklinikum Freiburg
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Ethics review
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Status: Approved
Approval date: 23/09/2014
Contact:
ekfr.mpg@uniklinik-freiburg.de
Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
+49-761-27072600
ekfr.mpg@uniklinik-freiburg.de
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